Minimally invasive procedures involving catheters, guidewires, needles, trocars, and other elongated medical instruments are commonly used in cardiology, radiology, neurology, urology, and other medical specialties accessing the vascular system and other anatomies. These medical devices serve to navigate the vasculature and guide other therapeutic devices to particular anatomical locations in the patient depending on the procedure. The individual characteristics of these devices are defined by their intended use, from the diagnosis and treatment of vascular disease to the transfer of fluids to and from the human body.
Catheters consist of an elongated shaft with a lumen that is inserted into the body percutaneously or via a natural orifice. The curved distal portion of a catheter is specially designed for facilitating insertion into the body and requires precise consideration for the specific radius of the catheter and the catheter diameter. The flexible distal region allows the catheter the freedom to navigate through the intricate anatomies such as the vasculature and reach those areas previously inaccessible.
The concept of a tube-like structure inserted into the body to perform a task is not a new one. Modern procedures are performed through the use of preformed catheters purchased by healthcare facilities based on frequency of use. Curved catheters have become a necessary progression from the straight catheter to facilitate selective locating (as in a renal or coronary vessel) from a remote entry site.
During the course of a procedure, it may become necessary to change the catheter to one of a smaller or larger curve radius and/or smaller or larger catheter diameter. The diameter variations in a human vessel can be affected by the age, gender and size of the patient. Therefore, each procedure presents a unique set of criteria necessary to provide the patient with the best possible care. It is expected that the required variations of curve radius or catheter size would be readily available and quickly accessible to the healthcare professionals. However, it is currently impossible for a health care facility to prepare for every possible eventuality by stocking every conceivable catheter size and curve radius. Consequently, health professionals are forced to choose the closest possible catheter diameter with the closest radius curve for their patients' individual needs. Albeit to a lesser extent, these same considerations also apply to other medical devices that navigate the vasculature to reach specific anatomies.
Containing health-care costs continues to be important, so efforts to minimize expenditures are continuously considered. In particular, budgets are being scrutinized for ways to eliminate unnecessary spending or to find ways to make the spending more effective. The cost of inventorying a wide variety of medical device lengths, diameters, and curve shapes in an effort to anticipate patient anatomical demands is expensive.
Over the years, attempts have been made to improve catheter curvature. For example, U.S. Pat. No. 8,197,453 relates to a catheter having increased curve performance through heat treatment.
U.S. Patent Application Publication No. 2003/0114831 relates to a catheter having improved curve retention and a method of manufacture.
U.S. Pat. No. 3,719,737 relates to a method of making a preformed curved epidural catheter.
U.S. Pat. No. 7,378,048 relates to a method for forming catheter curves.
U.S. Pat. No. 5,619,993 relates to a method of controlling curvature of a medical device.
U.S. Pat. No. 4,292,270 relates to a method and apparatus for making coude catheters.
U.S. Pat. No. 3,839,841 relates to a method for forming and sterilizing catheters.
U.S. Patent Application Publication No. 2010/0147048 relates to devices, systems and methods for automated wire bending.
U.S. Pat. No. 7,134,310 relates to a tube bender.
U.S. Pat. No. 8,298,242 B2 relates to a system for the bending of an elongate member.
U.S. Pat. No. 2011/0265538 A1 relates to a system for the multidimensional bending of an elongate member.
U.S. Pat. No. 3,866,458 relates to a bender for contouring surgical implants.
U.S. Pat. No. 6,644,087 B1 relates to a rod bender for bending surgical rods.
U.S. Pat. No. 6,755,064 B2 relates to a bending method and robotic device used to add curvature to orthodontic archwires and other medical devices.
U.S. Patent No. 2003/0055435 A1 relates to a system for shaping orthopaedic implants.
U.S. Patent No. 2010/0069882 A1 relates to an elongated medical device that exhibits preferential bending.
U.S. Patent No. 2013/009121 A1 relates to a handheld rod bender.
U.S. Patent No. 2003/0114831 A1 relates to a method for treating polymeric materials suitable for catheter construction with a nucleating agent.
U.S. Patent No. 2003/0199818 A1 relates to a series of temperature-activated actuators that impart a curve on an elongated medical device.
U.S. Patent No. 2010/0159117 A1 relates to a superelastic guidewire with shape retention tip.
U.S. Pat. No. 7,378,048 B2 relates to a method and apparatus for forming catheters and catheter curves using ferromagnetic materials exposed to an alternative magnetic field.
U.S. Pat. No. 5,761,950 relates to a tube bender.
U.S. Pat. No. 5,502,997 relates to a gripper and mandrel assembly for a stretch type tube bender.
U.S. Pat. No. 5,593,708 relates to an apparatus for bending a plastic pipe.
U.S. Pat. No. 7,918,819 B2 relates to a deflectable tip guiding device with a variable curve on the tip.
U.S. Pat. No. 5,619,993 relates to a pressure source used to control the curvature of a medical device.
U.S. Pat. No. 5,809,824 relates to a tool for producing a loop in a straight wire.
U.S. Pat. No. 8,006,534 B1 relates to a wire or rod bender adaptable to bend a variety of sizes of wire to at least one desirable angle.
U.S. Patent No. 2010/0147048 A1 relates to devices, systems, and methods for automated wire bending.
U.S. Pat. No. 5,669,258 relates to a manual tube bender with angle indicator.
U.S. Pat. No. 7,134,310 relates to a tube bender including a pushing device, guide rail, and curved bending die.
U.S. Pat. No. 6,487,889 B1 relates to a tube bender that is able to bend multiple tubes at various angles.
Patent No. EP 0417865 B1 relates to the method of manufacture of a drainage catheter.
Patent No. EP 0600676 A2 relates to a steerable catheter with an adjustable bend location.
Patent No. EP 1301140 B1 relates to a bending machine for a medical device, more specifically an orthodontic archwire.
Patent No. EP 2172288 A1 relates to a bending method for suture needles.
Accordingly, each of the aforementioned proposals has limitations and there is still a need for novel apparatuses, systems, and methods which create medical device curves.